Clinical Trials Project Manager

🕒 September 24

🗽 New York – Remote

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💵 $80k - $100k / year

⏰ Full Time

🟢 Junior

👷‍♀️ Project Manager

🚫👨‍🎓 No degree required

👻 Ghost score 11%

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Logo of Rochester Regional Health

Rochester Regional Health

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

📚 Education

Healthcare • Healthcare Insurance • Education

Rochester Regional Health is an integrated health services organization serving the people of Western New York. It operates multiple hospitals and healthcare facilities, providing a wide range of healthcare services, including emergency care, primary care, specialty clinics, and urgent care. The organization is committed to medical education and research, offering training programs, residencies, and clinical trials. Rochester Regional Health focuses on comprehensive care with emphasis on treating patients respectfully and meeting their diverse medical needs across all stages of life.

📋 Description

• Liaise with ACM Global Central Laboratory clients as the primary point of contact • Represent laboratory aspects of clinical trial conduct and coordinate internally across all groups • Manage 10 to 25 protocols after training, depending on scope and complexity • Review clinical protocols and assist with protocol set-up • Develop Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions • Participate in and document clinical trial quality audits and inspections • Evaluate and communicate monthly project metrics and analyze trial activity, including monthly budget reviews • Conduct investigator training sessions by telephone or at investigator meetings • Travel to client events and ACM international locations • Ensure study conduct meets client goals and timelines; troubleshoot and solve problems • Manage regulatory study documentation, collection, maintenance, and archiving • Develop protocol-specific procedures as needed • Follow company policies, procedures, and applicable clinical laboratory regulations

🎯 Requirements

• 1+ years project management experience • Bachelor’s Degree (preferred) • Experience working in a clinical trial, laboratory or healthcare setting (preferred) • General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions • Ability to travel overnight, including weekend days • Passport qualifications for international travel • Ability to perform on-call coverage duties as assigned • Ability to maintain patient and client confidentiality • Sedentary work capacity with prolonged sitting and lifting under 10 lbs • Fine motor skills and clear visual and auditory ability • Valid driver’s license may be required for some roles

🏖️ Benefits

• Overnight travel and travel to client events and ACM international locations • On-call coverage duties as assigned • Additional pay components may be eligible • Potential accommodations for reported physical requirements

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